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Standards of quality and safety of organs intended for transplantation

The therapeutic use of organs poses certain risks which should be limited by a judicial framework covering all stages of the process from donation to transplantation. The safety and quality of organs should be guaranteed, as should the protection of donors and recipients through the competent authorities.

ACT

Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

SUMMARY

This Directive sets out a common framework on quality and safety standards for organs * of human origin intended for transplantation into the human body. It also aims to protect donors * and optimise exchanges between Member States and third countries.

Scope

This Directive covers only those organs to be transplanted into the human body, and not the use of organs for the purposes of research.

It applies to:

  • donation *;
  • procurement *;
  • testing;
  • characterisation *;
  • transport;
  • transplantation of organs.

It does not apply to:

  • blood;
  • blood components;
  • human tissues and cells;
  • organs, tissues and cells of animal origin.

Quality and safety of organs

Member States shall implement a quality and safety framework which defines the parameters of all stages of the chain from donation to transplantation *.

These quality and safety frameworks are to fix all of the parameters of the process continuously, from donation to transplantation. They have the following functions in particular:

  • to define traceability * procedures from donation to transplantation or disposal of the organ;
  • to implement standard operating procedures *;
  • to establish the qualifications of personnel.

The procurement of an organ (that has previously been subject to a characterisation) is to be performed in dedicated facilities and under the supervision of a medical doctor as defined in Directive 2005/36/EC.

All procured organs must be characterised before transplantation. The minimum information required includes:

  • le type of donor;
  • the blood group;
  • the cause and date of death of the donor;
  • the clinical history of the donor, including aspects such as neoplasia, hepatisis, HIV or IV drug abuse.

Other complimentary information may be requested, such as the medical history of the donor or, for example, physical and clinical data.

The transport of organs shall be carried out according to clearly defined criteria. The shipping containers used by organisations or companies must contain information such as contact details for the procurement and transplantation organisations, be marked ‘handle with care’ and contain safety instructions and method of cooling.

All organs procured, allocated and transplanted on the territory must be traceable from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.

If a serious adverse event should occur following organ transplantation, a reporting system, put in place by Member States, should allow relevant information to be reported and transmitted.

Donor and recipient protection

Organ donation must be voluntary and unpaid. However, compensation may be granted to make good the expenses and loss of income related to the donation, while avoiding any financial incentive.

Member States shall be prohibited from advertising the need for, or availability of, organs.

Living donors are to be provided with comprehensive information as to the purpose and nature of the donation, and the consequences and risks involved.

Qualified medical personnel are to select donors on the basis of their health and medical history including a psychological evaluation. These provisions guarantee the quality and safety of organs.

The personal data of the donor shall be protected in line with Directive 95/46/EC. Anonymity is guaranteed.

Competent authorities

Member States shall designate the competent authorities to implement the Directive. They will, in particular, supervise the implementation of the quality and safety framework and exchanges with Member States or third countries;

Context

Over the last 20 years, the use of human organs for transplantation has increased considerably. This technique makes it possible to compensate for the failure of organs such as the liver, lungs or heart. However, this medical practice is associated with risks which this Directive aims to reduce by introducing strict standards concerning the quality and safety of organs.

Key terms used in the act
  • Organ: a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy;
  • Donor: every human source of organs, whether living or deceased;
  • Donation: donating human organs for transplantation;
  • Transplantation: the process of restoring certain functions of the human body by transferring equivalent organs to a recipient;
  • Traceability: the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, this authority, under specified circumstances set out in this Directive being authorised to: identify the donor and the procurement organisation, identify the recipient(s) at the transplantation centre(s), locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ;
  • Standard operating procedures: written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end product;
  • Procurement: a process by which the donated organs become available;
  • Donor characterisation: the collection of the relevant information on the characteristics of the donor needed to undertake a proper risk assessment in order to minimise the risks for the recipient and to optimise organ allocation.

REFERENCE

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal

Directive 2010/53/EU

26.8.2010

27.8.2012

OJ L 207 of 6.8.2010

RELATED ACTS

Communication from the Commission of 8 December 2008 - Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States” [COM (2008) 819 final - Not published in the Official Journal].
The Action Plan on Organ Donation and Transplantation (2009-2015) sets out 10 priority actions in this area.

Last updated: 08.10.2010
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